FDA PMA/510(k) Submissions

Next Generation Sequencing Company

ResearchDx is your single provider of all Diagnostic development and regulatory services. Our team of scientists, statisticians, medical writers and regulatory experts can handle every step of the regulatory process, from initial concept to regulatory approval and commercialization. We can help make it easy to pass the FDA regulations with our CLIA-Approved Lab. We’ve helped many clients bring products to market through idea generation, product development, and management. We can help minimize the cost of and the time needed to pass through the submission process, and help develop the clinical trial using GLP and cGMP measures.

Our unparalleled experience gives us an edge on our competitors and our attention to our clients’ individual needs increases their chances of a quick and cost-effective approval. At ResearchDx, we demand success.

PMA/510(k) Submissions

Every new IVD assay and product must be accepted by the FDA through a Pre-market Notification (PMN), also known as a 510(k), to evaluate the safety and effectiveness of the medical device in question. Some devices that sustain human life, are vital to a person’s health, or have a potential to threaten it must also submit a Pre-Market Approval (PMA) to further gauge the specific safety and effectiveness of such products.

At ResearchDx, we work with our clients to do any or all of the following:

  • Initial Assay design and development
  • 510k documentation preparation
  • Determining whether a PMA is needed
  • Listing the product-specific documents
  • Statistician hiring for data management
  • FDA Pre-Submission (PRE-IDE) process
  • Special 510k (Device Modification)
  • Abbreviated 510k Submissions
  • Substantial Equivalence (SE) Comparison
  • 510(k) Summary Statement
  • FDA Labeling
  • Indications for Use
  • 510k Device Description
  • Performance Compliance 21 CFR 807.87 D
  • Class III Certification and Summary (for Class III only)
  • Final Certification and Disclosure Statement for 510k notifications with Clinical Studies
  • 510k Kit Certification
  • Sterilization Methods
  • Software Documentation
  • Third Party Review by Accredited Persons (AP)
  • Coordinate fees
  • Expedited Review